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Browse Device Recalls

84 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 84 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 84 FDA device recalls.

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DateProductReasonClassFirm
Jun 14, 2019 Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750S... The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack ... Class II CooperSurgical, Inc.
Apr 23, 2019 LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The... 2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appr... Class II CooperSurgical, Inc.
Mar 27, 2019 ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0 ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent Class II CooperSurgical, Inc.
Sep 4, 2018 Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Us... There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing ... Class II CooperSurgical, Inc.
Sep 4, 2018 Colpo-Pneumo Occluder, Part CPO-6 The seal of the sterile pouch may be compromised, thereby increasing the risk of infection. Class II CooperSurgical, Inc.
Mar 12, 2018 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 c... Products have been packaged with the wrong Trocar length type. Class II CooperSurgical, Inc.
Mar 12, 2018 Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151 Products have been packaged with an incorrect product size. Class II CooperSurgical, Inc.
Oct 6, 2017 Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz... The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a ... Class II CooperSurgical, Inc.
Apr 10, 2017 CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit an... The current secondary packaging, a box, incorrectly states that the product is latex free. The pr... Class II CooperSurgical, Inc.
Aug 25, 2016 Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawi... Products contain international package insert and not the correct USA package insert Class III CooperSurgical, Inc.
Aug 25, 2016 Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freez... Products contain international package insert and not the correct USA package insert Class III CooperSurgical, Inc.
Feb 16, 2016 Milex Arcing Diaphragm Size 95; Model Number: MXWS95 The products have been identified to contain an incorrect size Diaphragm. Class II CooperSurgical, Inc.
Sep 14, 2015 MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 ... The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packagin... Class III CooperSurgical, Inc.
Sep 1, 2015 CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Elect... Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains ... Class III CooperSurgical, Inc.
Jul 6, 2015 Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSu... Product marketed without a 510(k) Class II CooperSurgical, Inc.
Jun 19, 2015 Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage... Incorrect expiration date on outer carton kit label Class II CooperSurgical, Inc.
May 20, 2015 MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80 A diaphragm size 80 labeled box was incorrectly packaged with a size 85. Class II CooperSurgical, Inc.
May 18, 2015 Ally Uterine Positioning System (Ally UPS) used in the mounting and position... Design of device may expose user to injury to fingers or body parts Class II CooperSurgical, Inc.
Apr 13, 2015 McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expo... Small sized specula were incorrectly packaged in printed bags for the medium sized speculum Class II CooperSurgical, Inc.
Mar 20, 2015 Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in... The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may n... Class II CooperSurgical, Inc.
Mar 9, 2015 WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; L... Internal gas line may malfunction causing the line to burst under pressure. Class II CooperSurgical, Inc.
Feb 9, 2015 CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02 Incorrect size printed on the Milex Pessary Kit packaging label Class II CooperSurgical, Inc.
Jan 26, 2015 NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand... Products without expiration date have the remote potential for minor burn Class II CooperSurgical, Inc.
Jan 26, 2015 Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Bran... Products without expiration date have the remote potential for minor burn Class II CooperSurgical, Inc.
Jan 26, 2015 CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant ... Products without expiration date have the remote potential for minor burn Class II CooperSurgical, Inc.
Jan 26, 2015 MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid ... Products without expiration date have the remote potential for minor burn Class II CooperSurgical, Inc.
Oct 27, 2014 CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft... Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Ra... Class II CooperSurgical, Inc.
Oct 27, 2014 Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgic... The product has been identified to contain an incorrect curette type. Class III CooperSurgical, Inc.
Sep 30, 2014 CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: ... Incorrect expiration date printed on the MILEX PESSARY KIT packaging Class III CooperSurgical, Inc.
Sep 30, 2014 CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Mode... Incorrect expiration date printed on the MILEX PESSARY KIT packaging Class III CooperSurgical, Inc.
Jul 3, 2014 CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonograph... Unsealed pouches. Class II CooperSurgical, Inc.
May 13, 2014 Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonograph... Sterility of the device may be compromised due to unsealed pouch Class II CooperSurgical, Inc.
Sep 13, 2013 Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparosc... CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed... Class II CooperSurgical, Inc. D.B.A. Lone Star Medical P...
May 1, 2013 CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421... Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification Class II CooperSurgical, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.